Usually prescribed when other medicines or treatments have failed,
Remicade belongs to a class of drugs called tumor necrosis factor
inhibitors (TNFs),
which work by suppressing the action of a protein called TNF, which has
been tied to inflammation.

Doctors also prescribe Remicade "off label" to treat Takayasu disease,
a rare disorder that causes inflammation of large arteries.

The FDA first approved Remicade for adult Crohn's disease in 1998, and
extended approvals to other immune system diseases, including
rheumatoid arthritis
in 2004, ulcerative colitis in 2005, pediatric Crohn's in 2006, and
pediatric ulcerative colitis in 2011.

Manufactured and sold by Johnson& Johnson subsidiary Janssen
Biotech, Remicade, like all biologics â€” which are made from living
material â€” cannot be
easily copied, and so there are no generic versions of the drug.

The FDA is still working out its plan for regulating and approving
biologic knockoffs, or "biosimilars," which, while not exact replicas
of the brand name
drugs, have the same active ingredients and show the same clinical
effectiveness.

Two biosimilars for Remicade have been approved by the European Union:
Remsima, from South Korea's Celltrion, and Inflectra, from U.S.-based
Hospira.
Remicade is given through a needle placed in a vein, and can only be
administered by a health care professional. The needle needs to remain
in place for
about two hours. Since Remicade can raise the risk of infections,
patients must take steps to avoid illness and injury.

Remicade (Infliximab) Warnings

The Food and Drug Administration (FDA) has issued a black-box warning
for Remicade because of the risk of serious, sometimes fatal,
infections, such as
tuberculosis (TB), bacterial sepsis, invasive fungal infection,
Listeria,
and Legionnaire's disease in patients receiving the drug.

There are also reports of lymphoma and other cancers in children and
adolescents taking TNFs, including Remicade, for Crohn's disease and
ulcerative
colitis.

Before starting the treatment, let your doctor know if you have ever
had TB, or been exposed to it. All patients should be evaluated for
tuberculosis risk
factors and be tested for latent tuberculosis infection (with a
tuberculin skin test or blood-based interferon-gamma release assay)
prior to starting
Remicade.Also let your doctor know if
you ever lived in a region (such as Ohio or the Mississippi River
Valleys) where certain fungal
infections are common, have recurring infections, diabetes, an immune
system disorder, any type of cancer , any heart condition, hepatitis B,
multiple
sclerosis, or Guillain-Barre syndrome.

Mention any allergies, too, and any vaccines you're planning to have,
as adults and children on Remicade should not receive live vaccines.

During its years on the market, Remicade has had its share controversy
amid a growing list of black-box warnings. In 2013, the FDA updated the
label for
Remicade and adalimumab (Humira), another TNF blocker, to include a
warning for skin cancer, noting that it tended to develop in children
and young adults.

The manufacturer has also spent time in court, defending itself against
claims that it failed to adequately warn patients about some of
Remicade's
potential side effects. In 2006, a Texas jury awarded $19.4 million to
a woman taking Remicade for Crohn's disease â€” she claimed the drug
company failed to
adequately warn about the "lupus-like syndrome" she experienced while
on the drug.

Pregnancy and Remicade (Infliximab)

Remicade is in the FDAâ€™s Pregnancy Category B, meaning that there is no
evidence of risk to a womanâ€™s fetus if she takes Remicade during
pregnancy.

Nonetheless, you should always tell your doctor if you are pregnant,
plan to become pregnant, are breastfeeding, or used Remicade while
pregnant.

Call your doctor right away at any sign of infection, including
flu-like symptoms (cough and sore throat, chills, runny nose,
headaches, fatigue, nausea),
or any open cuts or sores on your body, or raw red or painful skin.

People 65 years and older are more vulnerable to serious and
potentially fatal viral, fungal, and bacterial infections, including
TB, while taking
Remicade.

Children who received Remicade in studies for Crohn's disease were more
prone to anemia, leukopenia (low white blood cell count), flushing,
viral and
bacterial infections, neutropenia (reduction in white blood cells that
specifically fight infection), bone breaks, and allergic reactions of
the
respiratory tract than adults with Crohn's who took Remicade.

Children taking Remicade for ulcerative colitis were also found to be
more vulnerable to infection than their adult counterparts.

Among the patients taking Remicade along with other TNF blockers for
Crohn's disease or ulcerative colitis, most of the patients who
developed
hepatosphlenic T-cell lymphoma were adolescent or young adult males.

Those who have been using Remicade for a long time, especially those
whose disease is very active, may be more likely to develop lymphoma.

Patients who have chronic obstructive pulmonary disease (COPD), a type
of lung cancer, or those who have had phototherapy treatment, may have
an increased
risk of getting cancer while on Remicade.

Remicade (Infliximab) Interactions

When you are taking Remicade, be sure to let your doctor know if you
are taking any of the following medicines:

Kineret (anakinra)

Orencia (abatacept)

Actemra (tocilizumab)

Other biologics used to treat the same conidtions as
Remicade: Humira
(adalimumab), Enbrel (etanercept), Cimzia (certolizumab), Simponi
(golimumab)

Remicade should not be taken together with these medications, as doing
so can increase the risk of infection.

You need to tell your doctor about all the medicines you take â€”
prescription and nonprescription, vitamins, illegal and recreational
drugs, and herbal and
dietary supplements â€” and especially if you were on another biologic to
treat the same conditions as Remicade.

Remicade (Infliximab) Dosage

Note that Remicade is dosed in milligrams (mg) per kilogram (kg) of the
patientâ€™s body weight.

Remicade comes in 100 mg vials and is given intravenously by a medical
professional. The recommended dosage is generally 5 mg/kg at 0, two,
and six weeks,
followed by a maintenance regimen of 5 mg/kg every eight weeks after
that.

Rheumatoid arthritis: The recommended dosage is 3 mg/kg,
used in
combination with methotrexate, a cancer drug that in lower does is an
anti-rheumatic
drug. Some patients benefit by increasing the dose to 10 mg/kg.

Crohn's disease: Some adult patients may benefit from
increasing the
regimen dosage to 10 mg/kg.

Ankylosing spondylitis: The maintenance regimen is
treatment every
six weeks, not every eight weeks.

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